|
Index of reports
> Cases resulting in other serious reactions (274)
> Cases with Sepsis (19)
Below is the selection of adverse event reports related to Prograf (Tacrolimus) that includes cases resulting in other serious reactions where reactions include sepsis.
Adverse event in 55 year old male receiving Prograf (Tacrolimus)
Reported by a health professional (non-physician/pharmacist) from Japan on 2007-10-26
Patient: 55 year old male
Adverse reactions / side effects: Blood Bilirubin Increased, Systemic Candida, Liver Disorder, Haematocrit Decreased, RED Blood Cell Count Decreased, Interstitial Lung Disease, White Blood Cell Count Decreased, Blood Urine Present, Alanine Aminotransferase Increased, Haemodialysis, Haemoglobin Decreased, Renal Impairment, Respiratory Failure, Blood Potassium Decreased, Aspartate Aminotransferase Increased, Sepsis, Cytomegalovirus Infection, Platelet Count Decreased, Shock
Adverse event resulted in: death, life threatening event
Suspect drug(s):
Ambisome
Dosage: 200 mg, uid/qd, iv drip
Indication: Systemic Candida
Start date: 2007-06-06
End date: 2007-06-29
Prograf
Dosage: 0.6 mg, uid/qd, iv drip
Indication: Drug USE FOR Unknown Indication
Mycamine
Dosage: 300 mg, uid/qd, iv drip
Indication: Systemic Candida
Start date: 2007-05-10
Vancomycin Hydrochloride
Dosage: 1 g, uid/qd, iv drip
Indication: Drug USE FOR Unknown Indication
Start date: 2007-06-15
Denosine(ganciclovir)
Dosage: 120 mg, uid/qd
Indication: Drug USE FOR Unknown Indication
Start date: 2007-05-08
Targocid
Indication: Drug USE FOR Unknown Indication
Bactramin(sulfamethoxazole)
Dosage: iv drip
Indication: Drug USE FOR Unknown Indication
Start date: 2007-06-06
Other drugs received by patient: Neupogen; Prednisone; Fragmin; Omeprazole; Vfend; Acyclovir; Maxipime; Viccillin-S; Ciproflaxacin; Meropen (Meropenem); Antithrombin III (Antithrombin Iii)
Adverse event in 69 year old male receiving Prograf (Tacrolimus)
Reported by a physician from France on 2007-10-26
Patient: 69 year old male
Adverse reactions / side effects: Actinic Keratosis, Skin Graft, Squamous Cell Carcinoma, Liver Disorder, Neoplasm Recurrence, Basal Cell Carcinoma, Neuroendocrine Carcinoma of THE Skin, Sepsis
Adverse event resulted in: death
Suspect drug(s):
Prograf
Dosage: 0.5 mg, bid; 1 mg, uid/qd
Indication: Liver Transplant
Start date: 1997-01-01
End date: 2004-01-01
Prograf
Dosage: 0.5 mg, bid; 1 mg, uid/qd
Indication: Liver Transplant
Start date: 2004-01-01
Other drugs received by patient: Prednisone TAB
Adverse event in 22 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-07-30
Patient: 22 year old male
Adverse reactions / side effects: Thrombosis, Histiocytosis Haematophagic, Gastrointestinal Haemorrhage, Hyperthermia, Duodenal Ulcer Perforation, Epstein-Barr Virus Infection, Malaise, Sepsis
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Basiliximab (Basiliximab) Formulation Unknown; Mycophenolate Mofetil; Steroid Formulation Unknown; Gamma Globulin (Immunoglobulin Human Normal) Formulation Unknown; Ganciclovir (Ganciclovir) Formulation Unknown; Aciclovir (Aciclovir) Formulation Unknown
Adverse event in 3 month old female receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-07-23
Patient: 3 month old female
Adverse reactions / side effects: Hepatic Function Abnormal, Graft Dysfunction, Sepsis, General Physical Health Deterioration
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Prednisolone
Adverse event in 60 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-07-23
Patient: 60 year old male
Adverse reactions / side effects: Sepsis, Pyothorax
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Cyclophosphamide; Mycophenolate Mofetil; PGE 1 (Alprostadil)
Adverse event in 74 year old female receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-07-23
Patient: 74 year old female, weighing 40.0 kg (88.0 pounds)
Adverse reactions / side effects: Adenovirus Infection, Disseminated Intravascular Coagulation, Sepsis, Platelet Count Decreased, Pyrexia, Neutrophil Count Decreased
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Cellcept
Administration route: Oral
Start date: 2006-02-28
End date: 2006-03-29
Cellcept
Dosage: discontinued.
Administration route: Oral
Start date: 2006-04-03
End date: 2006-06-19
Rituxan
Dosage: discontinued
Start date: 2006-03-28
End date: 2006-03-29
Simulect
Dosage: reported as simulect (basiliximab (genetic recombination))
Start date: 2006-03-29
End date: 2006-03-29
Simulect
Start date: 2006-04-02
End date: 2006-04-02
Prograf
Administration route: Oral
Start date: 2006-03-25
End date: 2006-06-30
Solu-Medrol
Dosage: form reported as intravenous drip.
Indication: Drug USE FOR Unknown Indication
Start date: 2006-06-22
End date: 2006-06-25
Predonine
Administration route: Oral
Start date: 2006-04-03
End date: 2006-06-19
Adverse event in 5 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-06-05
Patient: 5 year old male, weighing 25.0 kg (55.0 pounds)
Adverse reactions / side effects: Drug Ineffective, Tonsillar Hypertrophy, Pancytopenia, Anaemia Haemolytic Autoimmune, Lymphoproliferative Disorder, Streptococcal Infection, Gastrointestinal Infection, Catheter Related Infection, Cyanosis, Staphylococcal Infection, Sepsis, Obstructive Airways Disorder
Adverse event resulted in: death, disablity
Suspect drug(s):
Prograf
Dosage: 0.5 mg, uid/qd, iv drip
Indication: Bone Marrow Transplant
Start date: 2005-08-31
End date: 2005-09-09
Prograf
Dosage: see image
Administration route: Oral
Indication: Bone Marrow Transplant
Start date: 2005-09-10
End date: 2006-01-10
Prograf
Dosage: see image
Administration route: Oral
Indication: Bone Marrow Transplant
Start date: 2006-01-11
End date: 2006-04-20
Other drugs received by patient: Methotrexate Formulation Unknown; Cyclophosphamide (Cyclophosphamide) Formulation Unknown; Busulfan (Busulfan) Formulation Unknown; Fludara (Fludarabine Phosphate) Formulation Unknown; Medrol; Flumarin (Flomoxef Sodium) Injection; Prodif Injection; Prednisolone; Prednisolone
Adverse event in 61 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Germany on 2007-05-07
Patient: 61 year old male, weighing 79.0 kg (173.8 pounds)
Adverse reactions / side effects: Pulmonary Embolism, Cholestasis, Hepatic Failure, Constipation, Disease Progression, Acute Graft Versus Host Disease in Skin, Acute Graft Versus Host Disease in Intestine, Right Ventricular Failure, Refusal of Treatment by Patient, Pneumonia, Hepatic Fibrosis, Nephropathy Toxic, Gastric Ulcer Haemorrhage, Renal Cyst, DRY Skin, Cystitis, Convulsion, Hepatocellular Damage, Cholelithiasis, Epstein-Barr Virus Infection, Syncope, Renal Failure, NO Therapeutic Response, Hepatic Congestion, Dehydration, Sepsis, Cytomegalovirus Infection, Hepatic Siderosis, Human Herpesvirus 6 Infection, Leukopenia
Adverse event resulted in: death, life threatening event, hospitalization
Suspect drug(s):
Posaconazole
Dosage: 200 mg; qid; po
Administration route: Oral
Indication: Fungal Infection
Start date: 2005-11-03
Prograf
Dosage: 4 mg; po
Administration route: Oral
Indication: Prophylaxis Against Graft Versus Host Disease
Start date: 2005-12-16
End date: 2006-02-23
Acyclovir
Dosage: 200 mg; bid; po
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2005-12-22
End date: 2006-02-22
Other drugs received by patient: Sandimmune; Decortin; Cellcept; Ganciclovir; Beloc ZOC Comp; Decortin; Klacid; Magnesium Sulfate; Lasix; Dopamin; Calcium Chloride; Kalinor RET; Pantozol; Metoclopramide; Cymeven; Ciprofloxacin HCL; Amitriptyline HCL; Doxyciclin; Zyvox; Entocort; ..; Avelox; Albumin (Human); Fortum; Lopedum; Elobact; Entocort; Albumin (Human); Spirocomb; Perfalgan; Meronem; Omeprazole; Arternol; Kybernin; Mirtazapine; Paracetamol; .; Metoprolol Succinate; Kalinor RET
Adverse event in 58 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-04-17
Patient: 58 year old male
Adverse reactions / side effects: Pneumonia, Abdominal Abscess, Pneumocystis Jiroveci Infection, Sepsis, Cytomegalovirus Infection, Transplant Rejection, Bone Disorder
Adverse event resulted in: death
Suspect drug(s):
Prograf
Indication: Liver Transplant
Rituximab (Rituximab (Rituximab) Formulation Unknown
Dosage: 375 mg/m2, unknown/ d, unknown
Other drugs received by patient: Methylprednisolone; Prednisolone; Mycophenolate Mofetil; Methylprednisolone; Prostaglandin E1 (Alprostadil) Injection; Heparin
Adverse event in male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-04-05
Patient: male, weighing 55.0 kg (121.0 pounds)
Adverse reactions / side effects: Hyperbilirubinaemia, Disseminated Intravascular Coagulation, Condition Aggravated, Chronic Graft Versus Host Disease, Sepsis, Platelet Count Decreased, Blood Pressure Decreased, Oxygen Saturation Decreased, Renal Failure Acute
Adverse event resulted in: life threatening event
Suspect drug(s):
Mylotarg
Indication: Acute Leukaemia
Start date: 2006-05-16
End date: 2006-05-16
Acyclovir
Indication: Prophylaxis
Start date: 2006-05-14
End date: 2006-05-27
Acyclovir
Start date: 2006-06-04
Meropen
Dosage: unknown daily dose
Indication: Sepsis
Start date: 2006-05-14
End date: 2006-05-25
Vfend
Indication: Sepsis
Start date: 2006-05-16
Targocid
Indication: Sepsis
Start date: 2006-05-19
Gaster
Administration route: Oral
Indication: Prophylaxis
Start date: 2006-05-14
End date: 2006-05-17
Prograf
Administration route: Oral
Indication: Graft Versus Host Disease
Start date: 2006-05-27
End date: 2006-06-01
Cytarabine
Dosage: unknown daily dose
Indication: Acute Leukaemia
Start date: 2006-05-12
End date: 2006-05-14
Cytarabine
Dosage: unknown daily dose
Start date: 2006-06-30
End date: 2006-07-02
Other drugs received by patient: Ciprofloxacin; Ganciclovir; Urso; Blopress; Blopress; Omepral; Morphine; Biofermin R; Adsorbin; Lopemin; Amlodin; Amlodin; Rebetol; Hycamtin; Hycamtin; Hycamtin; Hycamtin; Hycamtin
Adverse event in 58 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-04-03
Patient: 58 year old male
Adverse reactions / side effects: Transplant Rejection, Blood Immunoglobulin G Decreased, Pneumonia Cytomegaloviral, Pneumocystis Jiroveci Pneumonia, Abdominal Abscess, Sepsis, Bone Marrow Failure, Hypogammaglobulinaemia
Adverse event resulted in: death
Suspect drug(s):
Prograf
Indication: Liver Transplant
Rituximab(rituximab) Formulation Unknown
Dosage: 375 mg/m2/d
Other drugs received by patient: Methylprednisolone; Prednisolone; Mycophenolate Mofetil; Methylprednisolone; Prostaglandin E1 (Alprostadil); Heparin
Adverse event in 47 year old male receiving Prograf (Tacrolimus)
Reported by a health professional (non-physician/pharmacist) from Brazil on 2007-03-28
Patient: 47 year old male
Adverse reactions / side effects: Pneumonia, Pulmonary Tuberculosis, Anaemia, Sepsis, Impaired Gastric Emptying
Adverse event resulted in: death
Suspect drug(s):
Prograf
Indication: Liver Transplant
Mycophenolate Mofetil
Indication: Liver Transplant
Corticosteroids
Indication: Liver Transplant
Benznidazole(benznidazole)
Dosage: 200 mg bid oral
Administration route: Oral
Indication: Prophylaxis
Adverse event in 42 year old male receiving Prograf (Tacrolimus)
Reported by a health professional (non-physician/pharmacist) from Brazil on 2007-03-28
Patient: 42 year old male
Adverse reactions / side effects: Hepatic Artery Thrombosis, Sepsis, Cholangitis, General Physical Health Deterioration
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Mycophenolate Mofetil; Corticosteroids; Benznidazole (Benznidazole)
Adverse event in 58 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-03-19
Patient: 58 year old male
Adverse reactions / side effects: Abdominal Abscess, Pneumocystis Jiroveci Infection, Sepsis, Transplant Rejection, Bone Marrow Failure, Pneumonia Cytomegaloviral
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Rituximab (Rituximab); Methylprednisolone; Prednisolone; Mycophenolate Mofetil; Methylprednisolone; Prostaglandin E1 (Alprostadil) Injection; Heparin
Adverse event in 75 year old female receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-03-07
Patient: 75 year old female
Adverse reactions / side effects: Renal Failure, Disseminated Intravascular Coagulation, Sepsis, Thrombotic Thrombocytopenic Purpura, Pyelonephritis
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Prednisolone (Prednisolone) Tablet, 1 MG; Onealfa (Alfacalcidol) Tablet, 1 UG; Hypen (Etodolac) Tablet, 200 MG; Depromel (Fluvoxamine) Tablet, 25 MG; Lendormin (Brotizolam) Tablet, 0.25 MG; Almarl (Arotinolol Hydrochloride) Tablet, 10 MG; EC Doparl (Benserazide Hydrochloride) Tablet
Adverse event in 75 year old female receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-02-26
Patient: 75 year old female
Adverse reactions / side effects: Renal Failure, Sepsis, Anorexia, Disseminated Intravascular Coagulation, Pyelonephritis
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Prednisolone; Onealfa (Alfacalcidol) Tablet; Etodolac; Depromel (Fluvoxamine) Tablet; Lendormin (Brotizolam) Tablet; Almarl (Arotinolol Hydrochloride) Tablet; EC Doparl (Benserazide Hydrochloride)
Adverse event in 30 year old female receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-02-15
Patient: 30 year old female
Adverse reactions / side effects: Meningoencephalitis Herpetic, Drug Ineffective, Sepsis, Nuclear Magnetic Resonance Imaging Abnormal, Amnesia, Human Herpesvirus 6 Infection, Convulsion
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Methotrexate (Methotrexate Sodium); Acyclovir; Ganciclovir; Foscarnet; Prednisolone
Adverse event in 52 year old female receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-02-15
Patient: 52 year old female
Adverse reactions / side effects: Meningoencephalitis Herpetic, Drug Ineffective, Sepsis, Human Herpesvirus 6 Infection, Convulsion
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Methotrexate (Methotrexate Sodium); Acyclovir; Prednisolone
Adverse event in 15 year old male receiving Prograf (Tacrolimus)
Reported by a physician from Japan on 2007-02-09
Patient: 15 year old male, weighing 33.0 kg (72.6 pounds)
Adverse reactions / side effects: Hepatic Necrosis, Drug Ineffective, Pain, Disseminated Intravascular Coagulation, Dyskinesia, Fall, Herpes Zoster, Multi-Organ Failure, Fungaemia, Gastric Mucosal Lesion, Blister, Restlessness, Cholecystitis Acute, Haemorrhage Intracranial, Grand MAL Convulsion, Pulmonary Haemorrhage, Renal Failure, Sepsis, Renal Hypertension, Pancreatitis
Adverse event resulted in: death
Suspect drug(s):
Prograf (Tacrolimus)
Other drugs received by patient: Methotrexate (Methotrexate Sodium); Acyclovir; Cyclosporine; Prednisolone
|
